Department of Defense (DOD) Research Requirements Checklist

Research that involves the Department of Defense (DOD) and any or all of its components is required to comply with specific DOD requirements. Quorum verifies compliance with such requirements at the time of research review. This document is for guidance and reference in ensuring that research involving the DOD complies with all specific DOD requirements.

1. Research is Required to Comply with DOD Requirements if:
(DOD Directive 3216.2, section 2 and enclosure 2 (section E.2.1.4); Under Secretary for Defense memorandum, March 2005, HA Policy 05-003.)
The study is funded by a component of the DOD
The study involves cooperation, collaboration, or other type of government agreement with a component of the DOD
This study uses property, facilities or assets of a component of the DOD
The subject population will intentionally include personnel (military and / or civilian) from a component of the DOD, or data or specimens from DOD personnel
2. General Requirements
2.1 Prohibitions or limitations related to DOD research
Captured or detained personnel
The DOD Directive 3216.2 (section 4.4.2) prohibits research involving prisoners of war. This includes any person captured, detained, held, or otherwise under the control of DOD personnel (military and civilian, or contractor employee). Such persons include enemy prisoners of war, civilian internees, retained persons, lawful and unlawful enemy combatants. Such persons do not include DOD personnel being held for law enforcement purposes.
Research involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C, and D.
For purposes of applying Subparts B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge.”
The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.
Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.
Research involving children cannot be exempt.
Waiver of consent
Waivers of informed consent are not allowed for research that involves an intervention or interaction with a human being as an experimental subject, which means for the primary purpose of obtaining data regarding the effect of the intervention or interaction (Title 10, USC, Section 980; Department of Defense Directive 3216.02 (March 25, 2002), section 4.2), except as follows:
Waivers of informed consent may be approved by the Head of the DOD component with respect to a specific research project to advance the development of a medical product necessary to the Armed Forces, if the research may directly benefit the subject and the research is carried out in accord with all other applicable laws and regulations, including 21 CRF 50.24.
This prohibition does not apply to screening of records for the purpose of identifying possible subjects and does not apply to retrospective records reviews. A waiver of consent is permissible for such activities.
Payment to active duty personnel
Unless on leave status or off-duty during participation, active duty personnel may not receive payment for participation except for blood donation. Payment for blood donation may not exceed $50 per blood draw. (Title 24, USC, Section 30; Title 18, USC, Section 209; DOD Directive 5500.7-R, sections 2-206 & 2-303).
Note that non-federal persons may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.
Classified research involving human subjects (DOD Directive 3216.02.13)
DOD-conducted non-exempt research involving human subjects that involves classified information as defined in Executive Order 13526 (Reference (r)) must follow the following requirements:
Involvement of classified information is limited to information needed for IRB approval and oversight of the research; information needed to inform the human subjects during the consent process; and information provided by the human subjects during the course of the research.
After IRB approval of the research, Secretary of Defense approval is required
Waivers of informed consent are prohibited
Informed Consent Procedures shall include
Identification of the DOD as the supporting institution of the research, unless the research involves no more than minimal risk. The Secretary of Defense may grant an exception to this requirement on the grounds that providing this information could compromise intelligence sources or methods.
A statement that the research involving human subjects is classified and an explanation of the impact of the classification.
Disclosure or use of classified information must comply with the requirements of Reference (r) for access to and protection of classified information.
IRB review must meet the following requirements
Expedited review is prohibited. IRB review shall be conducted using a full board review.
At least one non-affiliated member shall be a non-Federal employee.
Any IRB member who disagrees with a majority decision approving the research may appeal the decision to the Secretary of Defense.
The IRB shall determine whether potential human subjects need access to classified information to make a valid, informed consent decision.
Testing of chemical or biological agents
Research cannot involve the testing of chemical or biological agents, subject to possible exceptions for research for prophylactic, protective, or other peaceful purposes as described in Section 1520a of Title 50, United States Code, “War and National Defense” (also DOD Directive 3216.2 (section 4.4.5)).
Surveys or questionnaires administered to DOD personnel or their families
DOD review and approval is required. (DOD Instruction 1100.13). While IRB review of the surveys or questionnaires may take place prior to DOD approval, it is appropriate for the researcher, prior to IRB review, to consult with the specific DOD agency or institution involved in the research regarding any specific requirements related to the surveys or questionnaires.
Research involving consent by a legally authorized representative (LAR) on behalf of a subject
Research involving consent by an LAR on behalf of a subject who lacks capacity (due to age, condition, or other reason) to make a decision regarding consent to participate in the research is only permissible if the research is intended to be beneficial to individual subjects (DOD Directive 3216.2, section 4.2.1; Title 10, USC, Section 980).
The IRB is required to determine if the research is intended to be beneficial to the individual subjects; therefore, there must be sufficient information in the research protocol for the IRB to make such determination.
2.2 Training Requirements for DOD Funded Research
All personnel involved in reviewing, approving, supporting, conducting, managing, or overseeing research involving human subjects must complete initial and ongoing research ethics and human subjects protections training appropriate to each individual’s level of involvement, duties, and responsibilities. (Secretary of Navy SecNav Instruction 3900.39D). Additionally, the DOD component funding the research may evaluate the training or educational policies surrounding training, and determine additional training requirements.
2.3 Records and Documentation Requirements
Records maintained that document compliance or non-compliance with DOD requirements must be made accessible for inspection and copying by representatives of the DOD at reasonable times and in a reasonable manner.
3. Requirements for Greater Than Minimal Risk Research
3.1 Research Monitor. For more-than-minimal-risk* research, an independent monitor* must be appointed by name for the research. (DOD Directive 3216.2, section 4.4.3)
*“Minimal risk” is defined as: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (32 CFR 291.102(i)). DOD states that the phrase “ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” must not be interpreted to include the inherent risks certain categories of subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).
*There may be more than one research monitor if necessary due to required skills or experience. The monitor may be an ombudsman or a member of the data safety monitoring board.
3.2 The required monitor will be:
A medical research monitor
A non-medical research monitor
If the monitor is a non-medical research monitor, detail must be provided justifying having a non-medical as opposed to a medical monitor.
3.3 The Monitor’s duties and responsibilities must be described, including a description of what will be monitored:
Subject recruitment and consent
Subject enrollment
Study procedures
Confidentiality
Adverse events and protocol deviations / violations
Data and specimen collection
Data and specimen storage
Data analysis
Other
3.4 The activities the monitor will perform must be indicated:
Discuss research project with the lead researcher
Interview some or all subjects
Consult on individual cases
Evaluate adverse event reports
Other
3.5 The monitor’s independence and authority must be confirmed, including whether the monitor:
Is independent of the research team
Possesses sufficient educational and professional experience to serve as a subject advocate
Will promptly report discrepancies or problems to the IRB
Has the authority to stop the research progress, remove individual subjects from the research, and take whatever steps are necessary to protect the safety and wellbeing of the subjects until the IRB can assess the monitor’s report
3.6 The Monitor’s full name must be included in the research
The Monitor’s name is:
3.7 The Monitor’s curriculum vitae must be included in the research:
The monitor’s curriculum vitae must describe the monitor’s educational and research credentials and experience, and any other pertinent qualifications. T
3.8 A letter from the Monitor accepting the role must be included in the research
Monitor acceptance letter included
3.9 Handling of research related injuries.
All DOD related research involving greater-than-minimal-risk must have an arrangement for emergency treatment and necessary follow-up of any research related injury (DOD Directive 3216.2, section 5.3.4). Such arrangement must be described in the research.
3.10 The following protections are required for research involving military personal and more than minimal risk (DOD Directive 3216.2, section 4.4.4):
Not applicable: Military personnel are not an intended population.
The researcher will ascertain that an individual’s decision about participation has not been influenced by unit officers or senior noncommissioned officers (NCOs).
The research will exclude unit officers and senior NCOs from solicitation / recruitment / consent sessions for units under their command.
The research will offer separate recruitment / consent sessions for officers and NCOs excluded from sessions held for their units.
An ombudsperson not connected in any way to the research or to the unit will be present to monitor group recruitment briefings where a percentage of the unit is being recruited to participate as a group, to monitor that the voluntary nature of individual participants is adequately stressed and that the information provided about the research is adequate and true.
Any additional protections
4. Reporting
The IRB must promptly (no longer than 30 days) report to the DOD Human Research Protection Officer (HRPO) the following:
Serious or continuing non-compliance
Suspensions or terminations of research
Unanticipated problems involving risks to subjects or others
Significant changes to the research protocol that are approved by the IRB
The results of the IRB continuing review
If there is a change in IRB
When the IRB is notified by any Federal department, agency, or national organizations that any part of the IRB’s Human Research Protection Program is under investigation for cause involving a DOD-supported research protocol
Significant communication between institutions conducting research and other federal departments and agencies, regarding compliance and oversight
5.  Air Force
This section only applies to research that involves the Air Force.
5.1 Research involving the Air Force must comply with these limitations:
Subjects who are military or civilian employees or members of any Air Force component:
The researcher will consult with each subject to determine whether participation in the research would affect the subject’s ability to mobilize for readiness, to perform duties, or to be available for duty. Normally, if participation could affect these abilities, the subject should not be considered for participation in the research. (Air force Instruction 40-402, section 3.2.1.)
Research-related medical emergencies:
Apparatus, instruments, and personnel will be available to deal with medical emergencies related to the research. (Air Force Instruction 40-402, section 2.7.11.)
Minors:
Minors may be used as subjects only when the research is intended to be of benefit to the subjects and satisfies one of the following set of conditions. (Air Force Instruction 40-402, section 3.2.2.)
Involves no more than minimal risk to subjects; or
Presents greater than minimal risk but presents the prospect of direct benefit for individual subjects and the IRB finds that:
The risk is justified by the anticipated benefit to the subject
The relationship of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.
Mentally disabled persons:
A mentally disabled or institutionalized mentally infirm person may not participate as a subject, unless the study would be impossible or meaningless if such subjects were excluded. (Air Force Instruction 40-402, section 3.2.3.) In addition:
The subject must give legally effective consent, or the subject’s legal guardian must give effective consent, according to local law.
The proposed research must be concerned with one or more of the following:
The diagnosis, treatment, prevention, or etiology of a particular impairment that inflicts the subjects.
Any other condition, from which the subjects are suffering, provided there is a direct potential benefit to the subjects and prior testing has proved the risk to be acceptable.
The effect of institutional life on the institutionalized mentally infirm subjects, and involves no appreciable risk to the subjects.
Prisoners
A prisoner may not participate as a subject unless the proposed research is concerned with the diagnosis, treatment, prevention, or etiology of a particular impairment that afflicts the prisoner and unless the prisoner may derive a direct potential benefit. (Air Force Instruction 40-402, section 3.2.4.)